N/A
Completed N=300
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Human Immunodeficiency Virus Infection · Risk Reduction · Alcohol Abuse · Depression, Anxiety
Source: ClinicalTrials.gov NCT03912753 ↗
Enrolled (actual)
300
Serious AEs
0.7%
Results posted
Sep 2025
Primary outcomePrimary: Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days — 5.03; 6.40; 3.14; 2.37 condomless anal sex acts
Summary
The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men.
GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat or by reading about health information. This study also involves testing for HIV, syphilis, chlamydia, and gonorrhea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days |
5.03; 6.40; 3.14; 2.37; 3.35; 2.60 | — |
| PRIMARY Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days |
5.74; 5.32; 3.85; 3.06; 3.25; 2.80 | — |
| SECONDARY Score on Alcohol Use Disorders Identification Test (AUDIT-C) |
5.14; 5.10; 4.24; 4.20; 4.05; 3.86 | — |
| SECONDARY Score on Center for Epidemiologic Studies Depression Scale (CES-D) |
22.06; 21.44; 17.30; 18.66; 17.80; 17.90 | — |
| SECONDARY Score on Beck's Anxiety Inventory (BAI) |
15.20; 15.64; 10.73; 11.64; 9.55; 11.02 | — |
Eligibility Criteria
Inclusion Criteria
Gay and bisexual men (GMB) will be eligible if they report:
- Male sex at birth and current male identity;
- At least 16 years old;
- ≥ 1 act of condomless anal sex with an HIV-positive or status-unknown male partner in the prior month;
- ≥ 2 heavy drinking days in the prior month;
- Own a mobile device (smartphone, tablet, laptop); and
- Are confirmed to be HIV-negative upon testing at study baseline.
Exclusion Criteria
- GMB will be excluded if they report past-year: a) psychiatric hospitalization; b) psychotic and manic symptoms; or c) current mood-stabilizing or anti-psychotic medication prescription
- Any condition that, in the principal investigators' judgment, interferes with safe study participation.
Data sourced from ClinicalTrials.gov (NCT03912753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.